Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease

Sponsor

Mesoblast, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00543374

Collaborator

(none)

Enrollment

Locations

Arms

43.3

Actual Duration (Months)

1.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Protocol 610 is enrolling subjects who successfully achieved clinical benefit (reduction in Crohn's Disease Activity Index (CDAI) of at least 100 points) in Protocol 603. Protocol 610 is evaluating the length of initial effect of PROCHYMAL® adult human mesenchymal stem cells and the ability of these cells to successfully re-induce clinical benefit.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease	Drug: Placebo Drug: PROCHYMAL adult human mesenchymal stem cells	Phase 3

Detailed Description

A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment.

PROCHYMAL® adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic.

Protocol 610 is an extension study offered only to those subjects who successfully achieved clinical benefit (reduction of CDAI of at least 100 points) in Protocol 603.

Study Design

Study Type:

Interventional

Actual Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Durability and Retreatment Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Maintenance and Re-induction of Clinical Benefit and Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease

Actual Study Start Date :

Sep 17, 2007

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Apr 28, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo
Active Comparator: PROCHYMAL Low dose Low dose (total of 600 million cells)	Drug: PROCHYMAL adult human mesenchymal stem cells intravenous infusion four times over two weeks; possibly repeated once
Active Comparator: PROCHYMAL High dose High dose (total of 1200 cells)	Drug: PROCHYMAL adult human mesenchymal stem cells intravenous infusion four times over two weeks; possibly repeated once

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Placebo

Drug: Placebo

Placebo

Active Comparator: PROCHYMAL Low dose

Low dose (total of 600 million cells)

Drug: PROCHYMAL adult human mesenchymal stem cells

intravenous infusion four times over two weeks; possibly repeated once

Active Comparator: PROCHYMAL High dose

High dose (total of 1200 cells)

Drug: PROCHYMAL adult human mesenchymal stem cells

intravenous infusion four times over two weeks; possibly repeated once

Outcome Measures

Primary Outcome Measures

Duration of clinical benefit (Crohn's disease activity index) [6 months]
Re-induction of clinical benefit (Crohn's disease activity index) [6 months]

Secondary Outcome Measures

Improvement in quality of life (Inflammatory Bowel Disease Questionnaire [IBDQ] instrument) [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participation in Osiris Protocol 603, with drop of at least 100 points in CDAI at Day 28

Exclusion Criteria:

Substance abuse
Failure to receive full dose of all interventions in Protocol 603

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Clinical Research Institute	Anaheim	California	United States	92801
2	Veteran's Administration Medical Center (does not require vet status)	Long Beach	California	United States	90822
3	University of Southern California University Hospital	Los Angeles	California	United States	90033
4	University of California, San Francisco	San Francisco	California	United States	94115
5	Western States Clinical Research	Wheat Ridge	Colorado	United States	80033
6	Gastroenterology Center of Connecticut	Hamden	Connecticut	United States	06518
7	Clinical Research of West Florida	Clearwater	Florida	United States	33765
8	Borland-Groover Clinic	Jacksonville	Florida	United States	32256
9	Venture Research Institute	Miami	Florida	United States	33162
10	Shafran Gastroenterology Center	Winter Park	Florida	United States	32789
11	Atlanta Gastroenterology Associates	Atlanta	Georgia	United States	30342
12	University of Chicago Medical Center	Chicago	Illinois	United States	60637
13	Carle Clinic Association	Urbana	Illinois	United States	61801
14	Indiana University Medical Center	Indianapolis	Indiana	United States	46202
15	Cotton-O'Neil Clinical Research Center	Topeka	Kansas	United States	66606
16	University of Kentucky Hospital	Lexington	Kentucky	United States	40536
17	University of Louisville Hospital	Louisville	Kentucky	United States	40202
18	Gulf Coast Research	Baton Rouge	Louisiana	United States	70808
19	National Institutes of Health	Bethesda	Maryland	United States	20892
20	Metropolitan Gastroenterology Group	Chevy Chase	Maryland	United States	20815
21	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
22	Brigham and Womens Hospital	Boston	Massachusetts	United States	02115
23	Clinical Pharmacology Study Group	Worcester	Massachusetts	United States	01610
24	Center for Clinical Studies	Dearborn	Michigan	United States	48124
25	Center for Digestive Health	Troy	Michigan	United States	48098
26	University of Minnesota Hospital	Minneapolis	Minnesota	United States	55455
27	St Louis Center for Clinical Studies	Saint Louis	Missouri	United States	63128
28	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
29	Gastroenterology Research Associates	Cedar Knolls	New Jersey	United States	07927
30	Holy Name Hospital	Teaneck	New Jersey	United States	07666
31	Weill Cornell Medical College	New York	New York	United States	10028
32	Mount Sinai School of Medicine	New York	New York	United States	10029
33	Rochester Institute for Digestive Diseases	Rochester	New York	United States	14607
34	Rochester General Hospital	Rochester	New York	United States	14621
35	University Hospital and Medical Center	Stony Brook	New York	United States	11794
36	Charlotte Gastroenterology and Hepatology	Charlotte	North Carolina	United States	28207
37	Pinehurst Medical Clinic	Pinehurst	North Carolina	United States	28734
38	Wake Forest University	Winston-Salem	North Carolina	United States	27157
39	Dayton Science Institute	Dayton	Ohio	United States	45415
40	Gastroenterology United of Tulsa	Tulsa	Oklahoma	United States	74135
41	Options Health Research	Tulsa	Oklahoma	United States	74137
42	Allegheney Center for Digestive Health	Pittsburgh	Pennsylvania	United States	15212
43	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
44	Gastroenterology Center of the Midsouth	Germantown	Tennessee	United States	37138
45	Nashville GI Specialists	Nashville	Tennessee	United States	37205
46	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
47	Baylor University Medical Center	Dallas	Texas	United States	75246
48	University of Texas Medical Branch	Galveston	Texas	United States	77555
49	Memorial Hermann Hospital	Houston	Texas	United States	77030
50	University of Vermont	Burlington	Vermont	United States	05401
51	Digestive and Liver Disease Specialists	Norfolk	Virginia	United States	23502
52	McGuire Research Institute	Richmond	Virginia	United States	23249
53	Seattle Gastroenterology Associates	Seattle	Washington	United States	98133
54	University of Calgary	Calgary	Alberta	Canada	T2N 4N1
55	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G 2X8
56	Health Sciences Centre	Winnipeg	Manitoba	Canada	R3A 1R9
57	London Health Sciences Centre	London	Ontario	Canada	N6A 5A5
58	Mount Sinai Hospital	Toronto	Ontario	Canada	M5G 1X5

Sponsors and Collaborators

Mesoblast, Inc.

Investigators

Study Director: Mahboob Rahman, MD, Mesoblast, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mesoblast, Inc.

ClinicalTrials.gov Identifier:

NCT00543374

Other Study ID Numbers:

CRD 610

First Posted:

Oct 15, 2007

Last Update Posted:

Dec 28, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Crohn Disease

Remestemcel-l

Study Results

No Results Posted as of Dec 28, 2021