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Clinical Trial Results:
The utilization of mesenchymal stem cells (MSC) for the treatment of graft versus host disease (GVHD) after allogeneic stem cell transplantation.

Summary
EudraCT number	2013-003626-88
Trial protocol	CZ
Global end of trial date	17 Dec 2019

Results information
Results version number	v1(current)
This version publication date	15 Jul 2022
First version publication date	15 Jul 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

HOO-MSC01

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

University Hospital Pilsen

Sponsor organisation address

Alej Svobody 80, Pilsen, Czechia, 30460

Public contact

Hematologicko-onkologické oddělení, Fakultní nemocnice Plzeň, +420 377103 722, lysak@fnplzen.cz

Scientific contact

Hematologicko-onkologické oddělení, Fakultní nemocnice Plzeň, 377103722 377103 722, lysak@fnplzen.cz

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

31 Dec 2019

Is this the analysis of the primary completion data?

Yes

Primary completion date

17 Oct 2019

Global end of trial reached?

Yes

Global end of trial date

17 Dec 2019

Was the trial ended prematurely?

Main objective of the trial

- Determine the efficiency and safety of mesenchymal stem cells infusion in patients with steroid refractory or steroid-dependent GVHD of any type. - Analyze changes in immunological laboratory parameters after the administration of mesenchymal stem cells.

Protection of trial subjects

All subjects were fully informed about possible alternative therapies and had the opportunity to withdraw the informed consent at any time without affecting their further treatment. The patients were treated according to the standard procedures of the transplant center during the clinical trial. The administration of immunosuppressive drugs was not affected by the study, and the dose of corticosteroids was reduced after the achievement of clinical response (relief of GVHD). In case of insufficient MSC effect or progression of GVHD symptoms, the use of alternative immunosuppressive protocols was allowed.

Background therapy

All patients were provided with prophylactic immunosuppressive therapy based on cyclosporine or mycophenolate mofetil. Corticosteroid therapy was indicated as first-line treatment of GVHD in all patients (acute GVHD at a dose of 0.87 (0.14 - 1.90) mg / kg / day, chronic GVHD - 0.25 (0.10 - 0, 86) mg / kg / day).

Evidence for comparator

It was an uncontrolled single-center study. All patients enrolled in the study were treated with the advanced therapy medical product. Neither the control group withoud MSC administration nor the control group with other alternative treatment interventions were used as comparators. There were two reasons for the absence of a control group. First, the establishment of a control group would extend the period for obtaining the expected number of subjects and, in particular, the inclusion of subjects in the control arm would not be ethically correct given the available literature on the likely benefit of MSCs in the context of steroid-refractory GVHD. Literature data available for second-line treatment of steroid-refractory GVHD were used to evaluate the efficacy, and non-inferiority of therapy with MSCs was analysed.

Actual start date of recruitment

11 Mar 2014

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

6 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Czechia: 37

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

It was a single-center clinical trial and all patients screened for the study were treated at a single transplant center - Department of Hematology and Oncology, University Hospital Pilsen, Czech Republic. The first subject was enrolled in 3/2014, the last visit of the last enrolled subject took place in 10/2019.

Screening details

The main criterion for entering the study was the condition after allogeneic hematopoietic stem cell transplantation for hematological malignancy and the development of first-line treatment refractory GVHD (steroid- refractory GVHD).

Period 1 title

overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

MSC arm

Arm description

Patients included into MSC arm were diagnosed with steroid-refractory or steroid-dependent GVHD after allogeneic stem cell transplantation. The participation of the subjects in the study began with the diagnosis of refractory GVHD and ended 12 months after MSC administration. The investigational medicinal product was the infusion of allogeneic mesenchymal stem cells expanded in vitro.

Arm type

Experimental

Investigational medicinal product name

mesenchymal stem cells

Investigational medicinal product code

not applicable

Other name

mesenchymal stromal cells, MSCs

Pharmaceutical forms

Infusion

Routes of administration

Infusion

Dosage and administration details

The medicinal product was a suspension of allogeneic mesenchymal stem cells in saline and human albumin (FR 1/1 + HSA) in a dose ranging from 1.0 to 5.0 x 10e9 / kg and a volume of approximately 300 ml. The product was applied as a single infusion in most patients, a total of 38% of patients received more than one dose of MSCs (2 doses 9x, 3 doses 3x and 4 doses 3x).

Number of subjects in period 1	MSC arm
Started	37
day+14	35
day+30	32
day+60	26
day+100	25
month+6	24
Completed	20
Not completed	17
Adverse event, serious fatal	16
Lost to follow-up	1

Baseline characteristics

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Reporting group title

overall trial

Reporting group description

Reporting group values	overall trial	Total
Number of subjects	37	37
Age categorical
Units: Subjects
In utero		0
Preterm newborn infants (gestational age < 37 wks)		0
Newborns (0-27 days)		0
Infants and toddlers (28 days-23 months)		0
Children (2-11 years)		0
Adolescents (12-17 years)		0
Adults (18-64 years)		0
From 65-84 years		0
85 years and over		0
Age continuous
age (median)
Units: years
median (full range (min-max))	54 (21 to 74)	-
Gender categorical
Units: Subjects
Female	19	19
Male	18	18
donor type
Units: Subjects
related HLA compatible	7	7
unrelated HLA compatible	19	19
haploidentical	5	5
unrelated mismatched	6	6
primary disease
type of primary malignant disorder
Units: Subjects
myeloid neoplasm	28	28
lymphoid neoplasm	9	9
GVHD grade
severity of GVHD at the time of MSC infusion
Units: Subjects
grade I/II	23	23
grade III/IV	14	14
time since transplantation to MSC infusion
median
Units: month
median (full range (min-max))		-

Subject analysis set title

acute GVHD

Subject analysis set type

Sub-group analysis

Subject analysis set description

subjects with acute GVHD (two patients not included into analysis due to early death before first time point - day+14)

Subject analysis set title

chronic GVHD

Subject analysis set type

Sub-group analysis

Subject analysis set description

patients with chronic GVHD

Subject analysis set title

day+0 lymphocyte aGVHD

Subject analysis set type

Per protocol

Subject analysis set description

analysis of lymphocyte subpopulations kinetics in aGVHD patients (dy+0 vs. day+60), only patients surviving after day+60 included

Subject analysis set title

day+60 lymphocyte aGVHD

Subject analysis set type

Per protocol

Subject analysis set description

analysis of lymphocyte subpopulations kinetics in aGVHD patients (dy+0 vs. day+60), only patients surviving after day+60 included

Subject analysis set title

day+0 lymphocyte chGVHD

Subject analysis set type

Per protocol

Subject analysis set description

analysis of lymphocyte subpopulations kinetics in chGVHD patients (dy+0 vs. day+60)

Subject analysis set title

day+60 lymphocyte chGVHD

Subject analysis set type

Per protocol

Subject analysis set description

analysis of lymphocyte subpopulations kinetics in chGVHD patients (dy+0 vs. day+60)

Subject analysis sets values	acute GVHD	chronic GVHD	day+0 lymphocyte aGVHD	day+60 lymphocyte aGVHD	day+0 lymphocyte chGVHD	day+60 lymphocyte chGVHD
Number of subjects	19	16	13	13	16	16
Age categorical
Units: Subjects
In utero
Preterm newborn infants (gestational age < 37 wks)
Newborns (0-27 days)
Infants and toddlers (28 days-23 months)
Children (2-11 years)
Adolescents (12-17 years)
Adults (18-64 years)
From 65-84 years
85 years and over
Age continuous
age (median)
Units: years
median (full range (min-max))	52 (21 to 69)	54 (33 to 65)
Gender categorical
Units: Subjects
Female	10	9
Male	9	7
donor type
Units: Subjects
related HLA compatible	3	4
unrelated HLA compatible	8	10
haploidentical	4	0
unrelated mismatched	4	2
primary disease
type of primary malignant disorder
Units: Subjects
myeloid neoplasm	14	13
lymphoid neoplasm	5	3
GVHD grade
severity of GVHD at the time of MSC infusion
Units: Subjects
grade I/II	8	14
grade III/IV	11	2
time since transplantation to MSC infusion
median
Units: month
median (full range (min-max))	3 (1 to 19)	24 (5 to 95)

End points

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Reporting group title

MSC arm

Reporting group description

Subject analysis set title

acute GVHD

Subject analysis set type

Sub-group analysis

Subject analysis set description

subjects with acute GVHD (two patients not included into analysis due to early death before first time point - day+14)

Subject analysis set title

chronic GVHD

Subject analysis set type

Sub-group analysis

Subject analysis set description

patients with chronic GVHD

Subject analysis set title

day+0 lymphocyte aGVHD

Subject analysis set type

Per protocol

Subject analysis set description

analysis of lymphocyte subpopulations kinetics in aGVHD patients (dy+0 vs. day+60), only patients surviving after day+60 included

Subject analysis set title

day+60 lymphocyte aGVHD

Subject analysis set type

Per protocol

Subject analysis set description

analysis of lymphocyte subpopulations kinetics in aGVHD patients (dy+0 vs. day+60), only patients surviving after day+60 included

Subject analysis set title

day+0 lymphocyte chGVHD

Subject analysis set type

Per protocol

Subject analysis set description

analysis of lymphocyte subpopulations kinetics in chGVHD patients (dy+0 vs. day+60)

Subject analysis set title

day+60 lymphocyte chGVHD

Subject analysis set type

Per protocol

Subject analysis set description

analysis of lymphocyte subpopulations kinetics in chGVHD patients (dy+0 vs. day+60)

Primary: response up to day+100

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End point title

response up to day+100

End point description

Response to the MSC treatment is based on the clinical symptoms, response is determined by comparison with the patient's baseline (at the time of enrollment in the clinical trial), response is defined as: CR (complete response), PR (partial response), SD (stable disease), PRG (progression) and ORR (overall response = CR + PR).

End point type

Primary

End point timeframe

dan+14 to day+100

End point values	acute GVHD	chronic GVHD
Number of subjects analysed	19	16
Units: percent
complete response	50	6
partial response	40	39
stable disease/progression	10	55

Attachments

Untitled (Filename: figure1_response_day100.pdf)

non-inferiority to historical data

Statistical analysis description

A non-inferiority test with the null hypothesis “new drug is as effective as the literature documented efficacy of standard treatment (set at 40% for aGVHD and 40% for cGVHD) was used for the analysis. An alternative hypothesis was - "new drug has a higher effectiveness than standard treatment". The non-inferiority margin was set at 5%. Standard treatment - effectiveness: 40%, non-inferiority margin: 5%.

Comparison groups

acute GVHD v chronic GVHD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[1]

P-value

< 0.0001 ^[2]

Method

Chi-squared

Parameter type

relative frequency (proportion)

Confidence interval

level

95%

sides

1-sided

lower limit

upper limit

Notes
[1] - New drug is not significantly worse that „gold standard“ => non-inferiority test is appropriate. The clinical success is defined as CR or PR best response within 100 days of Follow-up.
[2] - H0: p≤p(0)-m H1: p>p(0)-m p(0) = 30% m = 5% Statistical significance set as level alpha=2.5%.

Primary: lymphocyte subpopulations aGVHD

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End point title

lymphocyte subpopulations aGVHD

End point description

An analysis of the development of lymphocyte subpopulations - day+0 vs. day +60 - was performed (all patients who reached a given timepoint). The subpopulations CD3+CD8+, CD3+CD4+, NK cells and B-cells were analysed.

End point type

Primary

End point timeframe

the comparison of absolute lymphocyte counts in aGVHD: day+0 vs. day+60

End point values	day+0 lymphocyte aGVHD	day+60 lymphocyte aGVHD
Number of subjects analysed	13	13
Units: cells/microlitre
median (full range (min-max))
CD3+/CD4+	31 (6 to 273)	63 (3 to 449)
CD3+/CD8+	171 (10 to 1272)	384 (6 to 1148)
NK cells	40 (9 to 147)	88 (10 to 272)
B cells	7 (0 to 40)	10 (0 to 31)
Th1	0.3 (0 to 16.7)	2.1 (0.11 to 9.9)
Th2	0.8 (0.01 to 13.6)	1.9 (0.1 to 11.8)
Th17	0.8 (0.03 to 8.9)	1.0 (0.5 to 6.56)

Attachments

changes of lymphocytes populations

lymphocyte subpopulations

Comparison groups

day+0 lymphocyte aGVHD v day+60 lymphocyte aGVHD

Number of subjects included in analysis

Analysis specification

Post-hoc

Analysis type

equivalence

P-value

≤ 0.05

Method

Wilcoxon (Mann-Whitney)

Parameter type

Median difference (final values)

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Variability estimate

Standard deviation

Primary: lymphocyte subpopulations chGVHD

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End point title

lymphocyte subpopulations chGVHD

End point description

End point type

Primary

End point timeframe

the comparison of absolute lymphocyte counts in chGVHD: day+0 vs. day+60

End point values	day+0 lymphocyte chGVHD	day+60 lymphocyte chGVHD
Number of subjects analysed	16	16
Units: cells/microlitre
median (full range (min-max))
CD3+/CD4+	420 (27 to 1228)	476 (44 to 1414)
CD3+/CD8+	705 (99 to 2469)	649 (135 to 2238)
NK cells	212 (41 to 1153)	187 (23 to 1026)
B cells	69 (0 to 1135)	100 (1 to 1328)
Th1	0.5 (0.02 to 38.3)	0.9 (0 to 19.3)
Th2	0.5 (0.17 to 3.64)	0.9 (0.12 to 4.2)
Th17	1.9 (0.53 to 38.1)	2.3 (0 to 6.07)

Attachments

changes of lymphocytes populations

lymphocyte subpopulations

Comparison groups

day+0 lymphocyte chGVHD v day+60 lymphocyte chGVHD

Number of subjects included in analysis

Analysis specification

Post-hoc

Analysis type

equivalence

P-value

≤ 0.05

Method

Wilcoxon (Mann-Whitney)

Parameter type

Median difference (final values)

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Variability estimate

Standard deviation

Secondary: infusion toxicity

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End point title

infusion toxicity

End point description

Acute toxicity associated with MSCs (fever, allergies, headaches) is monitored.

End point type

Secondary

End point timeframe

2 hours after insusion of MSC

End point values	acute GVHD	chronic GVHD
Number of subjects analysed	19	16
Units: percent
infusion toxicity	0	0

No statistical analyses for this end point

Secondary: corticosteroids dose

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End point title

corticosteroids dose

End point description

expressed as percentage of initial dose (at the time of MSC infusion)

End point type

Secondary

End point timeframe

dan+14 to month+6

End point values	acute GVHD	chronic GVHD
Number of subjects analysed	10	16
Units: percentage
median (full range (min-max))
day+14	66 (30 to 100)	100 (21 to 100)
day+30	50 (0 to 179)	78 (21 to 100)
day+60	31 (0 to 80)	72 (10 to 100)
day+100	23 (0 to 120)	64 (17 to 100)
month+6	16 (8 to 77)	57 (12 to 100)

Attachments

Untitled (Filename: figure2_kinetics_of_corticosteroids.pdf)

No statistical analyses for this end point

Secondary: overall survival

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End point title

overall survival

End point description

percentage of aGVHD and chGVHD patients surviving 12 months after MSC infusion (probability of survival) figure: overall survival calculated from the date of MSC insusion, median

End point type

Secondary

End point timeframe

from infusion of MSC do mohth +12

End point values	acute GVHD	chronic GVHD
Number of subjects analysed	19	16
Units: percent
patients alive at M+12 (percentage)	41	94

Attachments

overall survival

No statistical analyses for this end point

Secondary: regulatory cells

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End point title

regulatory cells

End point description

initial value determined as 100%, then the change from day+0 (before application) analysed and expressed as percentage change from the original value

End point type

Secondary

End point timeframe

the comparison of regulatory cells presence from day+0 to day+60

End point values	acute GVHD	chronic GVHD
Number of subjects analysed	15 ^[3]	11 ^[4]
Units: percent
CD123 + DC increase	0	66
CD123+ D decrease	65	0
FoxP3+ T cell increase	0	47
FoxP+ T cells decrease	56	0

Attachments

changes of regulatory cells

Notes
[3] - patients alive on day+60 analysed
[4] - patients alive on day+60 analysed

No statistical analyses for this end point

Secondary: quality of life

Top of page

End point title

quality of life

End point description

evaluated as the accumulation of scores for a given QoL parameter for all patients adjusted by the number of patients in a given timepoint

End point type

Secondary

End point timeframe

day+0 to day+100 for acute GVHD; day+0 to month+12 for chronic GVHD

End point values	acute GVHD	chronic GVHD
Number of subjects analysed	13	16
Units: cumulative score
physical well-being day+0	12	12
physical well-being day+100	9	11
social/family well-being day+0	21	19
social/family well-being day+100	21	19
emotional well-being day+0	10	11
emotional well-being day+100	8	11
functional well-being day+0	15	13
functional well-being day+100	17	13

Attachments

quality of life

No statistical analyses for this end point

Secondary: OS subgroup analysis

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End point title

OS subgroup analysis

End point description

overal survival - comparison of subgroups based on response to the treatment on day+30 (CR x PR x SD(PRG), GVHD stage (2 x 3) and corticosteroids dose reduction on day+14 (more than 50 % x less than 50 % of the initial dose), expressed as OS medians

End point type

Secondary

End point timeframe

12 months

End point values	acute GVHD	chronic GVHD
Number of subjects analysed	19	16
Units: months
response CR	28	80
response PR	2	80
response SD/PRG	2	38
stage 3	5	35
stage (1) 2	19	26
corticosteroids over 50 %	14	14
corticosteroids below 50%	35	35

Attachments

survival curves aGVHD
survival curves chGVHD

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

The occurrence of adverse events (AEs) was monitored during the period up to day +30 from the application of the medicinal product. Serious adverse events (SAEs) were monitored during 12 months follow-up.

Adverse event reporting additional description

The incidence of infectious complications was monitored separately during the 12-month follow-up. All infectious complications were monitored, regardless of severity, ie some of them are documented concurrently as SAE. The reason for this methodology was a more comprehensive assessment of immunomodulatory effect of the medicinal product.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

(S)AE all patients

Reporting group description

all patients treated with MSCs within the clinical trial, regardless of the type of GVHD

Serious adverse events	(S)AE all patients
Total subjects affected by serious adverse events
subjects affected / exposed	22 / 37 (59.46%)
number of deaths (all causes)	16
number of deaths resulting from adverse events	15
Nervous system disorders
Epilepsy
subjects affected / exposed	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
General disorders and administration site conditions
Multi-organ disorder
subjects affected / exposed	10 / 37 (27.03%)
occurrences causally related to treatment / all	0 / 10
deaths causally related to treatment / all	0 / 10
Blood and lymphatic system disorders
Haemolysis
subjects affected / exposed	2 / 37 (5.41%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Respiratory, thoracic and mediastinal disorders
Pleural effusion
subjects affected / exposed	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Infections and infestations
Pneumonia bacterial
subjects affected / exposed	6 / 37 (16.22%)
occurrences causally related to treatment / all	0 / 6
deaths causally related to treatment / all	0 / 4
Pneumonia fungal
subjects affected / exposed	2 / 37 (5.41%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 1
Pneumonia viral
subjects affected / exposed	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Cystitis bacterial
subjects affected / exposed	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Enterocolitis bacterial
subjects affected / exposed	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Sepsis
subjects affected / exposed	2 / 37 (5.41%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	(S)AE all patients
Total subjects affected by non serious adverse events
subjects affected / exposed	9 / 37 (24.32%)
Vascular disorders
Thrombosis
Additional description: Thrombosis with pulmonary embolism
subjects affected / exposed	1 / 37 (2.70%)
occurrences all number	1
Oedema
Additional description: leg oedema
subjects affected / exposed	1 / 37 (2.70%)
occurrences all number	1
Nervous system disorders
Pain
Additional description: Vertebrogenic algic syndrome
subjects affected / exposed	1 / 37 (2.70%)
occurrences all number	1
Epilepsy
subjects affected / exposed	1 / 37 (2.70%)
occurrences all number	1
Immune system disorders
Graft versus host disease
Additional description: recurrence of aGvHD II.stage
subjects affected / exposed	1 / 37 (2.70%)
occurrences all number	1
Renal and urinary disorders
Renal failure
Additional description: renal insufficiency resolved afrer therapy
subjects affected / exposed	2 / 37 (5.41%)
occurrences all number	2
Musculoskeletal and connective tissue disorders
Hip fracture
subjects affected / exposed	1 / 37 (2.70%)
occurrences all number	1
Metabolism and nutrition disorders
Hyponatraemia
subjects affected / exposed	1 / 37 (2.70%)
occurrences all number	1

More information

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Were there any global substantial amendments to the protocol? Yes

10 Jun 2016

In 2016, an amendment to the clinical trial protocol was approved (Amendment 01 dated 10 June 2016), which brought the following changes: - repeated MSC applications in patients with suboptimal clinical response allowed (up to 4 insusions) - the expected number of subjects increased to 40 - 50 - separate subanalysis of patients with aGVHD and chGVHD sheduled to evaluate the clinical response.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

The design of the single-arm study does not allow an independent assessment of the effectiveness of MSCs; the evaluation is complicated by limited sample size and a large number of peri-transplant variables, that increase overall variability.

http://www.ncbi.nlm.nih.gov/pubmed/31863261
http://www.ncbi.nlm.nih.gov/pubmed/27516191
http://www.ncbi.nlm.nih.gov/pubmed/26143146
http://www.ncbi.nlm.nih.gov/pubmed/24548911
http://www.ncbi.nlm.nih.gov/pubmed/24077235

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Clinical trials

Clinical Trial Results:
The utilization of mesenchymal stem cells (MSC) for the treatment of graft versus host disease (GVHD) after allogeneic stem cell transplantation.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: response up to day+100

Primary: response up to day+100

Primary: lymphocyte subpopulations aGVHD

Primary: lymphocyte subpopulations aGVHD

Primary: lymphocyte subpopulations chGVHD

Primary: lymphocyte subpopulations chGVHD

Secondary: infusion toxicity

Secondary: infusion toxicity

Secondary: corticosteroids dose

Secondary: corticosteroids dose

Secondary: overall survival

Secondary: overall survival

Secondary: regulatory cells

Secondary: regulatory cells

Secondary: quality of life

Secondary: quality of life

Secondary: OS subgroup analysis

Secondary: OS subgroup analysis

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

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Clinical trials

Clinical Trial Results: The utilization of mesenchymal stem cells (MSC) for the treatment of graft versus host disease (GVHD) after allogeneic stem cell transplantation.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: response up to day+100

Primary: response up to day+100

Primary: lymphocyte subpopulations aGVHD

Primary: lymphocyte subpopulations aGVHD

Primary: lymphocyte subpopulations chGVHD

Primary: lymphocyte subpopulations chGVHD

Secondary: infusion toxicity

Secondary: infusion toxicity

Secondary: corticosteroids dose

Secondary: corticosteroids dose

Secondary: overall survival

Secondary: overall survival

Secondary: regulatory cells

Secondary: regulatory cells

Secondary: quality of life

Secondary: quality of life

Secondary: OS subgroup analysis

Secondary: OS subgroup analysis

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
The utilization of mesenchymal stem cells (MSC) for the treatment of graft versus host disease (GVHD) after allogeneic stem cell transplantation.